Senior Quality Engineer - Combination Products, Tech Transfer and Commercial

$133,280 - $172,480/Yr

Gilead Sciences - Belmont, CA

Full-time - Mid Level

Belmont, CA

Chemical Manufacturing

About the position

The Sr. Quality Engineer for Combination Products at Gilead plays a crucial role in ensuring the quality and compliance of new combination products during the commercial stage. This position involves collaborating with design and development teams, overseeing quality governance, and maintaining compliance with regulatory standards. The engineer will also be responsible for training, risk management, and addressing technical issues related to drug-device combination products.

Responsibilities

• Provide Quality oversight for the Commercial stage, including Design Transfer.
• Create/revise/execute SOPs to support combination product quality governance in the commercial stage.
• Evaluate design changes and provide quality input to support continuous improvement initiatives.
• Stay abreast of evolving regulatory requirements and ensure commercial products comply with applicable standards.
• Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards.
• Work cross-functionally with Subject Matter Experts from R&D, Clinical, and Operations to ensure the risk process is applied comprehensively.
• Create and provide Quality training as needed for cross functional stakeholders and CMOs.
• Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to address and resolve complex technical related drug device combination product, process and quality issues.
• Ensure that changes to commercial products are conducted in accordance with FDA QSR/QMSR, ISO 13485, and other applicable standards.
• Write and/or implement changes to controlled documents (eg, SOPs, Specifications, WIs, etc.) as needed.
• Maintain expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.
• Execute changes to quality processes to ensure conformance and continuous improvement.
• Work with management and department personnel to achieve goals and strategic initiatives.
• Support due diligence and internal or external audits/inspections as needed.
• Participate in annual product reviews and perform periodic review and update of DHF and RMF.
• Support complaints investigations and filter information back to the design and development team and CMOs.

Requirements

• Must have 6+ years of relevant experience and a Bachelor's degree in a Science or Engineering related field; or 4+ years of relevant experience with a Master's degree in a Science or Engineering related field.
• Medical device experience preferred.
• Demonstrates in-depth knowledge of Quality principles, concepts, industry practices, and standards.
• Previous experience with combination devices is preferred (ie, Autoinjectors, co-packaged kits, pre-filled syringes).
• Quality experience in both clinical and commercial products.
• Strong project management and process improvement skills.
• Demonstrates understanding of U.S. and international quality systems regulations/standards to adopt best in class systems/processes and drive continuous improvement initiatives.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
• Knowledge of ISO 14971 Risk Management tools (eg, Hazard Analysis/or Failure Mode Effects Analysis (FMEA) is preferred.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.

Nice-to-haves

• Experience with combination products in a commercial setting.
• Familiarity with FDA QSR/QMSR and ISO 13485 standards.
• Knowledge of quality improvement statistical methods.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.